MX2019006633A - Antibody formulations. - Google Patents

Antibody formulations.

Info

Publication number
MX2019006633A
MX2019006633A MX2019006633A MX2019006633A MX2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A MX 2019006633 A MX2019006633 A MX 2019006633A
Authority
MX
Mexico
Prior art keywords
formulations
antibody formulations
methods
trehalose
biotechnology
Prior art date
Application number
MX2019006633A
Other languages
Spanish (es)
Inventor
Yatin Gokarn
Isidro E Zarraga
Jonathan Zarzar
Thomas Patapoff
Christine Wurth
Original Assignee
Genentech Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51625441&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2019006633(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of MX2019006633A publication Critical patent/MX2019006633A/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/54—F(ab')2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Endocrinology (AREA)

Abstract

The invention provides stable aqueous pharmaceutical formulations comprising a therapeutic antibody, trehalose, a buffer, and optional surfactant, and having a pH in the range of about 5.5 to about 7.0. The invention also provides methods for making such formulations and methods of using such formulations. In the past years, advances in biotechnology have made it possible to produce a variety of proteins for pharmaceutical applications using recombinant DNA techniques.
MX2019006633A 2013-03-13 2015-09-02 Antibody formulations. MX2019006633A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201361780899P 2013-03-13 2013-03-13

Publications (1)

Publication Number Publication Date
MX2019006633A true MX2019006633A (en) 2021-12-08

Family

ID=51625441

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2015011425A MX365567B (en) 2013-03-13 2014-03-13 Antibody formulations.
MX2019006633A MX2019006633A (en) 2013-03-13 2015-09-02 Antibody formulations.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
MX2015011425A MX365567B (en) 2013-03-13 2014-03-13 Antibody formulations.

Country Status (18)

Country Link
US (3) US10010611B2 (en)
EP (2) EP3744345B1 (en)
JP (2) JP6511609B2 (en)
KR (2) KR102127085B1 (en)
CN (2) CN110538322A (en)
AR (1) AR095396A1 (en)
AU (2) AU2014243783B2 (en)
BR (1) BR112015022210A8 (en)
CA (1) CA2906057A1 (en)
HK (1) HK1212614A1 (en)
IL (2) IL240886B (en)
MX (2) MX365567B (en)
MY (2) MY189047A (en)
NZ (2) NZ711567A (en)
RU (2) RU2694055C2 (en)
SG (2) SG10201913932VA (en)
WO (1) WO2014160490A1 (en)
ZA (2) ZA201506981B (en)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102127085B1 (en) 2013-03-13 2020-06-26 제넨테크, 인크. Antibody formulations
EP3193932B1 (en) 2014-09-15 2023-04-26 F. Hoffmann-La Roche AG Antibody formulations
CN107206080B (en) 2015-01-28 2022-07-08 辉瑞公司 Stable aqueous anti-Vascular Endothelial Growth Factor (VEGF) antibody formulations
WO2017100722A1 (en) * 2015-12-09 2017-06-15 Cedars-Sinai Medical Center Methods for treating nephrotic syndrome
CN105920600A (en) * 2016-04-19 2016-09-07 上海景泽生物技术有限公司 Stable anti-VEGF (vascular endothelial growth factor) antibody preparation and application thereof
KR102533875B1 (en) 2016-06-27 2023-05-18 모르포시스 아게 Anti-CD19 Antibody Formulations
CN107384932B (en) 2016-08-31 2020-10-20 北京天广实生物技术股份有限公司 Anti-human CD20 humanized monoclonal antibody MIL62, preparation method and application thereof
EP3541413A2 (en) 2016-11-21 2019-09-25 Polpharma Biologics S.A. Aqueous pharmaceutical formulations
CN108686204A (en) * 2017-04-07 2018-10-23 浙江海正药业股份有限公司 Include the infliximab composition of histidine buffer system
US11865175B1 (en) 2017-04-28 2024-01-09 Cedars-Sinai Medical Center Post-transplantation prophylaxis and treatments for antibody-mediated rejection of solid organ transplant
CN107899020A (en) * 2017-08-11 2018-04-13 百奥泰生物科技(广州)有限公司 The compound and method of CD20 positive diseases treatment
CN107881160A (en) * 2017-08-11 2018-04-06 百奥泰生物科技(广州)有限公司 There are recombinant antibodies of unique sugar spectrum and preparation method thereof caused by a kind of CHO host cells edited as genome
JP2020535181A (en) * 2017-09-29 2020-12-03 ヤンセン バイオテツク，インコーポレーテツド A novel formulation that stabilizes low-dose antibody compositions
CA3085158C (en) * 2017-12-22 2023-04-04 Samsung Bioepis Co., Ltd. Liquid composition comprising vegf antagonist
CR20210435A (en) 2019-02-18 2021-09-20 Lilly Co Eli Therapeutic antibody formulation
US20230338526A1 (en) * 2019-10-12 2023-10-26 Bio-Thera Solutions, Ltd. Anti-cd20 antibody formulation and use of anti-cd20 antibody for treatment of cd20 positive diseases
CN115066262A (en) * 2020-03-04 2022-09-16 上海复宏汉霖生物技术股份有限公司 Pharmaceutical formulation comprising bevacizumab
WO2022265591A1 (en) * 2021-06-18 2022-12-22 Arven Ilac Sanayi Ve Ticaret Anonim Sirketi Pharmaceutical compositions of bevacizumab

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